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A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: Safety, reactogenicity and immunogenicity.

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机构： [1]National Centre of Toxicology (CENATOX), 31 Ave. and 114 Street, Marianao, Havana, Cuba [2]Finlay Vaccine Institute. 21st Ave. N 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba [3]Institute of Cybernetics, Mathematics and Physics. 15 Street N 551 between C and D Streets, Vedado, Havana, Cuba [4]Center of Molecular Immunology, 15th Ave. and 216 Street, Siboney, Playa, Havana, Cuba [5]Research Centre of Civil Defense, San José de las Lajas, Mayabeque, Cuba [6]National Coordinating Centre of Clinical Trials, 5th Ave. between 60 and 62 Ave., Miramar, Playa, Havana, Cuba [7]Chengdu Olisynn Biotech. Co. Ltd., and State Key Laboratory of Biotherapy and Cancer Center, West China Hospital, Sichuan University, Chengdu 610041, People’s Republic of China

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关键词： COVID-19 SARS-CoV-2 Coronavirus infection Vaccines Immunization schedule Adjuvants Immunopotentiator Neutralizing antibodies

摘要：

The Receptor Binding Domain (RBD) of the SARS-CoV-2 spike protein is the target for many COVID-19 vaccines. Here we report results for phase I clinical trial of two COVID-19 vaccine candidates based on recombinant dimeric RBD (d-RBD).We performed a randomized, double-blind, phase I clinical trial in the National Centre of Toxicology in Havana. Sixty Cuban volunteers aged 19-59 years were randomized into three groups (20 subjects each): 1) FINLAY-FR-1 (50 µg d-RBD plus outer membrane vesicles from N. meningitidis); 2) FINLAY-FR-1A-50 (50 µg d-RBD, three doses); 3) FINLAY-FR-1A-25 (25 µg d-RDB, three doses). The FINLAY-FR-1 group was randomly divided to receive a third dose of the same vaccine candidate (homologous schedule) or FINLAY-FR-1A-50 (heterologous schedule). The primary outcomes were safety and reactogenicity. The secondary outcome was vaccine immunogenicity. Humoral response at baseline and following each vaccination was evaluated using live-virus neutralization test, anti-RBD IgG ELISA and in-vitro neutralization test of RBD:hACE2 interaction.Most adverse events were of mild intensity (63.5%), solicited (58.8%), and local (61.8%); 69.4% with causal association with vaccination. Serious adverse events were not found. The FINLAY-FR-1 group reported more subjects with adverse events than the other two groups. After the third dose, anti-RBD seroconversion was 100%, 94.4% and 90% for the FINLAY-FR-1, FINLAY-FR-1A-50 and FINLAY-FR-1A-25 respectively. The in-vitro inhibition of RBD:hACE2 interaction increased after the second dose in all formulations. The geometric mean neutralizing titres after the third dose rose significantly in the group vaccinated with FINLAY-FR-1 with respect to the other formulations and the COVID-19 Convalescent Serum Panel. No differences were found between FINLAY-FR-1 homologous or heterologous schedules.Vaccine candidates were safe and immunogenic, and induced live-virus neutralizing antibodies against SARS-CoV-2. The highest values were obtained when outer membrane vesicles were used as adjuvant.https://rpcec.sld.cu/en/trials/RPCEC00000338-En.Copyright © 2022 Elsevier Ltd. All rights reserved.

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出版当年[2022]版：

大类 | 3 区医学

小类 | 3 区医学：研究与实验 3 区免疫学

最新[2023]版：

大类 | 3 区医学

小类 | 3 区免疫学 3 区医学：研究与实验

第一作者：

第一作者机构： [1]National Centre of Toxicology (CENATOX), 31 Ave. and 114 Street, Marianao, Havana, Cuba

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通讯机构： [2]Finlay Vaccine Institute. 21st Ave. N 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba [*1]Finlay Vaccine Institute. 21st Ave. N 19810 between 198 and 200 Streets, Atabey, Playa, Havana, Cuba

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A randomized, double-blind phase I clinical trial of two recombinant dimeric RBD COVID-19 vaccine candidates: Safety, reactogenicity and immunogenicity.

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